Cleared Traditional

APERTO Lucent MRI System

K233629 · Fujifilm Healthcare Americas Corporation · Radiology
May 2024
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K233629 is an FDA 510(k) clearance for the APERTO Lucent MRI System, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on May 10, 2024, 179 days after receiving the submission on November 13, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K233629 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2023
Decision Date May 10, 2024
Days to Decision 179 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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